OxytocinNCT03140709
Non-Invasive, Highly Specific Detection of Oxytocin in Biological Fluids
An observational study of Oxytocin and Pregnancy, run by Stanford University at 1 site in United States.
Trial summary
This study will aid in the development of a research instrument for rapid and highly sensitive detection of perinatal salivary oxytocin, by non-invasive means. There will be two study cohorts: Induction of labor cohort (20) and Cesarean delivery cohort (5) for a total of 25 participants.The standard clinical protocols… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: 25 generally healthy, pregnant adult women of all ethnicities, between the ages of 18 and 45, admitted for scheduled induction of labor or Cesarean section
Who may be able to join
- Generally healthy, pregnant woman (37-41 weeks)
- Scheduled for induction of labor (not already in active labor) or cesarean section
- Ages 18-45 years old
- ASA physical status 1 or 2
- Singleton pregnancy
- Able and willing to sign consent
Who cannot join
- Women with any significant medical or obstetric condition (such as gestational hypertension, diabetes,coagulopathy, and renal impairment)
- Morbid obesity (BMI greater than/equal to 40)
- In active labor upon arrival to L\&D
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital
Palo Alto, California, 94305
About this study
This study will aid in the development of a research instrument for rapid and highly sensitive detection of perinatal salivary oxytocin, by non-invasive means. There will be two study cohorts: Induction of labor cohort (20) and Cesarean delivery cohort (5) for a total of 25 participants.The standard clinical protocols for administering oxytocin to human subjects at Lucile Packard Children's Hospital will be followed. Oxytocin will be prescribed and dosed as per standard of care with no change due to study enrollment. The study will only involve sampling of saliva and blood.
The general hypothesis to be tested is that 1) the sensor will accurately report the levels of oxytocin in saliva samples as compared with standard reference methods and 2) the sensor yields rapid (<20 minutes) oxytocin results with minimal discomfort to subjects. Overall, this will allow to optimize the administration of oxytocin, and for a better understanding of the blood concentration and effects of oxytocin on mother and child.
Read the detailed description
Oxytocin, a neuropeptide hormone, plays an important role in the dynamic function of the brain and a variety of complex social behaviors including affiliation, sexual behavior, social recognition, and aggression. Oxytocin is best known for its role to facilitate the birth process through induction of uterine smooth muscle contractions. Oxytocin is primarily used to induce labor, and contract the uterus after delivery. Oxytocin is considered the first line uterotonic to prevent and treat uterine atony and manage postpartum hemorrhage. Currently, there is no instrument that is capable of point-of-care oxytocin detection. A practical research tool to monitor peripheral levels of both endogenous and exogenous oxytocin is therefore needed to better understanding the pharmacokinetics and pharmacodynamics of oxytocin in the mother, fetus and newborn. A better understanding of drug concentration and effect may lead to optimal dosing and better management of induction of labor and/or uterine atony after delivery.
With increased research on the importance of oxytocin monitoring, a bedside oxytocin monitor is envisioned that would allow healthcare professionals to improve our pharmacokinetic/dynamic understanding of oxytocin and to monitor and adjust the dose of oxytocin administered during childbirth. Currently, there is no instrument that is capable of point-of-care oxytocin detection.
- Being tested
- Oxytocin
- Keywords
- Salivary, Oxytocin, Induction, Labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin
Induction-Vaginal Delivery: Begin at 1mU/min IV infusion and increase by 2mU/30min q30min to a max of 30mU/min. Postpartum infusion adjusted to 2U/hr.
Cesarian Delivery: 1U bolus via IV at delivery, followed by 7.5U/hr up to 30U/hour max depending on uterine tone. Postpartum infusion adjusted to 2U/hr
| Study group | Role | What they receive |
|---|---|---|
| Induced vaginal delivery | Saliva samples will be obtained both during induction and infusion, every 15 minutes after each change in dose. An estimated total of 5 saliva samples will be collected from each patient. Therefore, the last collection point (sample 5) will be during the oxytocin infusion after the 4th dose change. In addition, 2 blood samples will be collected from 5 patients - one baseline sample and another sample at same time as last saliva sample. Receives: Drug: Oxytocin | |
| Cesarian delivery | A total of 3 saliva samples will be collected from each patient - one at baseline preoperative, one intrapartum at least 15 min after starting the standard 250 ml/h oxytocin infusion, and one postpartum in post-anesthesia care unit (PACU) at least 15 min after starting the standard 125 ml/h oxytocin infusion. Therefore, the last collection point (sample 3) will be during the oxytocin infusion in PACU. In addition, 1 blood sample will be collected from each patient in this cohort - at same time as last saliva sample. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of salivary oxytocin assay levels
Test novel aptamer-based electrochemical assay for the detection and quantification of salivary oxytocin
Measured: 15 minutes after dose change
Secondary outcomes (1)
Quantification of blood oxytocin levels
Standard of care detection protocol for oxytocin blood levels to compare sensitivity and specificity of aptamer-based electrochemical assay
Measured: 15 minutes after dose change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study startMay 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OxytocinStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Giner, Inc, Aptagen, LLC, Fraunhofer Center for Manufacturing Innovation, Rose Biotech, LLC
- Responsible party
- Principal investigator, Brendan Carvalho, Stanford University
- Investigators
- Brendan Carvalho, MBBCh MDCH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140709
- Sponsor's protocol ID
- 36843
- Status last verified
- May 2017
- First submitted
- 15 May 2016
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dyer RA, Butwick AJ, Carvalho B. Oxytocin for labour and caesarean delivery: implications for the anaesthesiologist. Curr Opin Anaesthesiol. 2011 Jun;24(3):255-61. doi: 10.1097/ACO.0b013e328345331c.
PubMed 21415725Butwick AJ, Coleman L, Cohen SE, Riley ET, Carvalho B. Minimum effective bolus dose of oxytocin during elective Caesarean delivery. Br J Anaesth. 2010 Mar;104(3):338-43. doi: 10.1093/bja/aeq004.
PubMed 20150347
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive, Highly Specific Detection of Oxytocin in Biological Fluids
- ClinicalTrials.gov ID
- NCT03140709
- Acronym / sponsor ID
- 36843
- Keywords
- Salivary, Oxytocin, Induction, Labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Giner, Inc, Aptagen, LLC, Fraunhofer Center for Manufacturing Innovation, Rose Biotech, LLC
- Study start
- May 2016 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will aid in the development of a research instrument for rapid and highly sensitive detection of perinatal salivary oxytocin, by non-invasive means. There will be two study cohorts: Induction of labor cohort (20) and Cesarean delivery cohort (5) for a total of 25 participants.The standard clinical protocols for administering oxytocin to human subjects at Lucile Packard Children's Hospital will be followed. Oxytocin will be prescribed and dosed as per standard of care with no change due to study enrollment. The study will only involve sampling of saliva and blood.
The general hypothesis to be tested is that 1) the sensor will accurately report the levels of oxytocin in saliva samples as compared with standard reference methods and 2) the sensor yields rapid (<20 minutes) oxytocin results with minimal discomfort to subjects. Overall, this will allow to optimize the administration of oxytocin, and for a better understanding of the blood concentration and effects of oxytocin on mother and child.
Detailed description
Oxytocin, a neuropeptide hormone, plays an important role in the dynamic function of the brain and a variety of complex social behaviors including affiliation, sexual behavior, social recognition, and aggression. Oxytocin is best known for its role to facilitate the birth process through induction of uterine smooth muscle contractions. Oxytocin is primarily used to induce labor, and contract the uterus after delivery. Oxytocin is considered the first line uterotonic to prevent and treat uterine atony and manage postpartum hemorrhage. Currently, there is no instrument that is capable of point-of-care oxytocin detection. A practical research tool to monitor peripheral levels of both endogenous and exogenous oxytocin is therefore needed to better understanding the pharmacokinetics and pharmacodynamics of oxytocin in the mother, fetus and newborn. A better understanding of drug concentration and effect may lead to optimal dosing and better management of induction of labor and/or uterine atony after delivery.
With increased research on the importance of oxytocin monitoring, a bedside oxytocin monitor is envisioned that would allow healthcare professionals to improve our pharmacokinetic/dynamic understanding of oxytocin and to monitor and adjust the dose of oxytocin administered during childbirth. Currently, there is no instrument that is capable of point-of-care oxytocin detection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induced vaginal delivery | – | Drug: OxytocinSaliva samples will be obtained both during induction and infusion, every 15 minutes after each change in dose. An estimated total of 5 saliva samples will be collected from each patient. Therefore, the last collection point (sample 5) will be during the oxytocin infusion after the 4th dose change. In addition, 2 blood samples will be collected from 5 patients - one baseline sample and another sample at same time as last saliva sample. |
| Cesarian delivery | – | Drug: OxytocinA total of 3 saliva samples will be collected from each patient - one at baseline preoperative, one intrapartum at least 15 min after starting the standard 250 ml/h oxytocin infusion, and one postpartum in post-anesthesia care unit (PACU) at least 15 min after starting the standard 125 ml/h oxytocin infusion. Therefore, the last collection point (sample 3) will be during the oxytocin infusion in PACU. In addition, 1 blood sample will be collected from each patient in this cohort - at same time as last saliva sample. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 25 generally healthy, pregnant adult women of all ethnicities, between the ages of 18 and 45, admitted for scheduled induction of labor or Cesarean section
Key inclusion criteria (6 listed)
- Generally healthy, pregnant woman (37-41 weeks)
- Scheduled for induction of labor (not already in active labor) or cesarean section
- Ages 18-45 years old
- ASA physical status 1 or 2
- Singleton pregnancy
Key exclusion criteria (3 listed)
- Women with any significant medical or obstetric condition (such as gestational hypertension, diabetes,coagulopathy, and renal impairment)
- Morbid obesity (BMI greater than/equal to 40)
- In active labor upon arrival to L\&D
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: PitocinInduction-Vaginal Delivery: Begin at 1mU/min IV infusion and increase by 2mU/30min q30min to a max of 30mU/min. Postpartum infusion adjusted to 2U/hr. Cesarian Delivery: 1U bolus via IV at delivery, followed by 7.5U/hr up to 30U/hour max depending on uterine tone. Postpartum infusion adjusted to 2U/hr | Drug | Cesarian delivery, Induced vaginal delivery |
Primary outcome
Quantification of salivary oxytocin assay levels
Time frame: 15 minutes after dose change
Test novel aptamer-based electrochemical assay for the detection and quantification of salivary oxytocin
1 secondary outcome
Quantification of blood oxytocin levels
Time frame: 15 minutes after dose change
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Background: PubMed 21415725Dyer RA, Butwick AJ, Carvalho B. Oxytocin for labour and caesarean delivery: implications for the anaesthesiologist. Curr Opin Anaesthesiol. 2011 Jun;24(3):255-61. doi: 10.1097/ACO.0b013e328345331c.
- Background: PubMed 20150347Butwick AJ, Coleman L, Cohen SE, Riley ET, Carvalho B. Minimum effective bolus dose of oxytocin during elective Caesarean delivery. Br J Anaesth. 2010 Mar;104(3):338-43. doi: 10.1093/bja/aeq004.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brendan Carvalho, MBBCh MDCH principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxytocin and Pregnancy, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of salivary oxytocin assay levels (time frame: 15 minutes after dose change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03140709, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.